Coordinating Center: Participatory Approach to Query Fulfillment and Analytic Tool Development

PCORnet®, the National Patient-Centered Clinical Research Network, has achieved a notable degree of success since 2015 in establishing a national network of networks and conducting early observational research and pragmatic trials at national scale. However, as a learning network, PCORnet® is committed to continually improving itself, incorporating a broad range of perspectives. Many opportunities exist to engage research and informatics expertise both within PCORnet Clinical Research Networks (CRNs) and from peer networks.  

The Coordinating Center for PCORnet: Participatory Approach to Query Fulfillment and Analytic Tool Development collaboration will build on the Coordinating Center’s current query and study management, as part of enhancing the network’s ability to conduct research that is meaningful to patients, produces valid evidence, is efficient without sacrificing rigor or inclusivity, and takes advantage of PCORnet’s mechanisms for large-scale studies.   

To reach these goals, this Phase 3 Coordinating Center for PCORnet will focus on broad participation across PCORnet and engagement with other successful research networks to align with evolving best practices and standards. These steps will bring to PCORnet state-of-the-art research capabilities and enable it to function effectively in an ecosystem with rapidly evolving standards. 

This Coordinating Center is the result of collaboration across all PCORnet CRNs. The proposed work is organized around four principles: 

• Incorporate current best practices in network informatics into PCORnet’s research 

• Broaden the PCORnet query platform to meet current analytic needs of stakeholders 

• Support design of studies that make optimal use of the network 

• Promote inclusion of stakeholders in query fulfillment and study conduct 

Consistent with these principles, the Coordinating Center will establish a governance structure for development of PCORnet’s data usage capacity that includes voices from CRNs as well as nonresearch stakeholders in prioritization of Coordinating Center Scope 3 effort. Similarly, the project is organized into functional units that are supported by a central core team at PEDSnet but encourage participation from across the network based on expertise and interest.  Objectives include: 

• Continued support and maintenance of the PCORnet Modular Program (PMP) architecture for query fulfillment across PCORnet 

• Expanded query platform–The center will create opportunities for CRNs to respond to queries using modern analysis tools such as R and Python, without sacrificing PCORnet’s current SAS file-distribution capability, and will make it possible for sites to participate in the rapid, iterative development that is current best practice for electronic health record data. Query response capability will be spread across multiple sites in PEDSnet, ADVANCE, GPC, INSIGHT, and PaTH. 

• Query-related data quality assessment–The center will make assessment of data fitness a standard part of request fulfillment, adapted to the needs of the request, and in collaboration with other groups in the Coordinating Center, and use the results to improve network data. 

• Expanded data access–The center will develop mechanisms for safe access to summary data through self-service tools and for more sophisticated interaction with network data via workbenches, adopting successful experience from networks like AllOfUs and OHDSI. 

• Adaptive computable phenotyping–The center will make use of the depth of PCORnet data and modern phenotyping methods to improve its ability to detect important clinical characteristics for study. 

• Rigorous study design principles–The center will codify clinical research and informatics expertise to allow study teams to design studies that operate effectively in PCORnet’s data and regulatory framework to produce reliable evidence efficiently and inclusively. 

• Effective reuse–The center will preserve and disseminate tools, data, and learnings in a discoverable repository to accelerate future work through access to validated resources. 

• Diversity, equity, and inclusion–The center will elicit a range of perspectives throughout its work, technical and otherwise, to make results more generalizable and responsive to the needs of more communities. 

• Interoperation–The center will adapt successes in research and informatics for use in PCORnet through use of standards, methodologic advances, and innovative approaches to participant recruitment and interaction to create more effective studies and to better meet requirements for regulatory research. 

This work will be undertaken in close collaboration with other Coordinating Center Scope 3 awardees, as well as research, informatics, advocacy, and regulatory partners to achieve the kind of pragmatic, patient-centered research that is at the center of PCORI’s mission.